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Treatment of Antenatal Chlamydia Infection

Information source: Obafemi Awolowo University Teaching Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chlamydia Trachomatis Infection in Pregnancy

Intervention: Amoxicillin (Drug); Erythromycin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Obafemi Awolowo University Teaching Hospital

Official(s) and/or principal investigator(s):
Temitope O Okunola, MB;BS, Principal Investigator, Affiliation: Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife

Summary

PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH ENDOCERVICAL SWAB. THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT. THE PARTICIPANTS WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS. THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO BE USED DURING THE TREATMENT. THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES VERSION 17.

Clinical Details

Official title: Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: completion of course of medication and microbiological clearance

Secondary outcome: drug discontinuation rates

Detailed description: AIM(S) OF THE RESEARCH TO ASSESS THE EFFICACY AND TOLERABILITY OF AMOXICILLIN COMPARED TO ERYTHROMYCIN IN TREATMENT OF ANTENATAL CHLAMYDIA INFECTION OBJECTIVES OF THE RESEARCH

- TO DETERMINE THE PREVALENCE OF CHLAMYDIA TRACHOMATIS INFECTION IN PREGNANCY

- TO COMPARE THE PROPORTION OF SUBJECTS WITH CLEARANCE OF ANTENATAL CHLAMYDIA TRACHOMATIS

INFECTION BETWEEN THE ERYTHROMYCIN AND AMOXICILLIN GROUPS

- TO COMPARE THE OCCURENCE OF SIDE EFFECTS BETWEEN THE TWO GROUPS

- TO COMPARE THE DRUG DISCONTINUATION RATES BETWEEN THE TWO GROUP

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Test positive to Chlamydia rapid screening kit 2. Estimated gestational age less than 36 weeks 3. Consent to participate in the study 4. Willingness or ability to comply with follow-up schedule Exclusion Criteria: 1. Antenatal patients whose gestational age is more than 36 weeks 2. History of reaction to any of the drugs 3. Women with low lying placenta or placenta Praevia 4. History of other antibiotics intake within two weeks of recruitment

Locations and Contacts

Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Ile Ife, Imesi Ile 220001, Nigeria
Additional Information

Related publications:

Alary M, Joly JR, Moutquin JM, Mondor M, Boucher M, Fortier A, Pinault JJ, Paris G, Carrier S, Chamberland H, et al. Randomised comparison of amoxycillin and erythromycin in treatment of genital chlamydial infection in pregnancy. Lancet. 1994 Nov 26;344(8935):1461-5.

Starting date: October 2013
Last updated: March 26, 2014

Page last updated: August 23, 2015

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